A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
Recruiting · NCT06291896 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MammoWave
What this trial is about
This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.
Who can take part
Age range
45 Years to 74 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women aged between 45 and 74 years
- Asymptomatic
- Signed informed consent form before starting any study activity
- Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC)
- Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection \[MLO\] of the right breast, craniocaudal projection \[CC\] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days
- Spontaneous willingness to comply with CIP and recommendations
Exclusion criteria
- Woman with breast prostheses
- Women with symptoms or some sign of suspected BC
- Women with BRCA1, 2, TP53 or previous BC
- Pregnant women
- Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation)
- Women with breast size larger than the largest MammoWave cup size
Where it is running
10 locations listed.
- Hospital Universitario Reina Sofía- Córdoba - Córdoba, Spain
- Champalimaud Foundation - Lisbon, Portugal
- Clínica Dr. Passos Ângelo in Lisbon - Lisbon, Portugal
- Hospital General Universitario Morales Meseguer - Murcia, Spain
- Pomeranian Medical University Hospital - Szczecin, Poland
- Complejo Hospitalario Universitario de Toledo - Toledo, Spain
- Az. San. Univ. Giuliano Isontina (ASU GI) - Trieste, Italy
- Diagnostic and Interventional Radiology, University Hospital Zurich - Zurich, Switzerland
- IRCCS Policlinico San Martino - Genova, Genova, Italy
- Ospedale San Giovanni Battista - USL Umbria 2 - Foligno, Perugia, Italy